Heart Failure Technologies, LLCv.CardioKinetix, Inc.

Patent Trial and Appeal Board

Jul 31, 2013

11151164 (P.T.A.B. Jul. 31, 2013)

Trials@uspto.gov Paper 12
Tel: 571-272-7822 Entered: July 31, 2013

UNITED STATES PATENT AND TRADEMARK OFFICE

_______________

BEFORE THE PATENT TRIAL AND APPEAL BOARD

_______________

HEART FAILURE TECHNOLOGIES, LLC
Petitioner

v.

CARDIOKINETIX, INC.
Patent Owner
_______________

Case IPR2013-00183
Patent 7,582,051
_______________

Before THOMAS L. GIANNETTI, MICHAEL J. FITZPATRICK, and
SCOTT E. KAMHOLZ, Administrative Patent Judges.

KAMHOLZ, Administrative Patent Judge.

DECISION
Denying Institution of Inter Partes Review
37 C.F.R. § 42.108

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Patent 7,582,051

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I. INTRODUCTION
A. Background
Heart Failure Technologies, LLC (“Petitioner”) filed a petition to institute an
inter partes review of claims 1 and 10 of U.S. Patent 7,582,051 (the “ ’051
patent”). Paper 4 (“Pet.”). Patent Owner CardioKinetix, Inc. timely filed a
preliminary response. Paper 10 (“Prelim. Resp.”). The standard for instituting an
inter partes review is set forth in 35 U.S.C. § 314(a), which provides as follows:
THRESHOLD.—The Director may not authorize an inter
partes review to be instituted unless the Director
determines that the information presented in the petition
filed under section 311 and any response filed under
section 313 shows that there is a reasonable likelihood
that the petitioner would prevail with respect to at least 1
of the claims challenged in the petition.
Petitioner presents the following grounds of unpatentability (Pet. 3):
References Basis Claims challenged
Murphy (Ex. 1002),
1

Khairkhahan (Ex. 1004),
2
and
Lane (Ex. 1006)
3

§ 103 1, 10
Murphy, Khairkhahan, and
Salahieh (Ex. 1007)
4

§ 103 1, 10
Lesh (Ex. 1003),
5
Khairkhahan,
Nikolic (Ex. 1005),
6
and Lane
§ 103 1, 10
Lesh, Khairkhahan, Nikolic,
and Salahieh
§ 103 1, 10

1
U.S. Patent 7,485,088 B2.
2
U.S. Pre-Grant Publication US 2002/0111647 A1.
3
U.S. Patent 7,717,955 B2.
4
U.S. Pre-Grant Publication US 2005/0137688 A1.
5
U.S. Patent 6,152,144.
6
U.S. Pre-Grant Publication US 2003/0050685 A1.
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We determine that the record before us does not demonstrate that there is a
reasonable likelihood that Petitioner would prevail with respect to at least one
challenged claim. We consequently deny the petition and decline to institute an
inter partes review of the ’051 patent.
B. The Invention
The ’051 patent (Ex. 1001) is entitled “Peripheral Seal for a Ventricular
Partitioning Device,” and relates generally to a device used to divide a heart
chamber into a productive portion and a non-productive portion. Abstr. The
device finds particular application in patients having hearts with weakened walls or
enlarged chambers, due to various forms of congestive heart failure. Col. 2,
ll. 38-45. Partitioning relieves stress on the weakened wall tissue and reduces
chamber volume, thereby improving the heart function measurement known as
ejection fraction. Id.
Figure 1 of the ’051 patent is reproduced below:

Figure 1 illustrates partitioning device 10. The device includes an
expandable frame 13 formed from ribs 14 that extend from hub 12 to free proximal
ends 16. Col. 5, ll. 45-51. Partitioning membrane 11 is secured to the frame and is
unfurled when the free proximal ends expand radially. Id. at ll. 53-54. When
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unfurled, the membrane presents a pressure receiving surface 17 (the undersurface,
not indicated in Fig. 1). Id. at ll. 53-55. The membrane has a peripheral edge 18
(also not indicated in Fig. 1) that may have serrations. Id. at ll. 57-58. A
continuous expansive strand 19 extends around the periphery of the membrane on
the undersurface. Id. at 59-60. The strand applies pressure to the membrane to
seal the periphery to the wall of the ventricular chamber. Id. at 60-63. The strand
is biased outwardly and ensures that folds or wrinkles are not formed when the
device is expanded for deployment. Col. 3, l. 66 to col. 4, l. 2.
Claim 1 illustrates the claimed subject matter and is reproduced below:
1. A device for treating a patient by partitioning a
chamber of the patient's heart into a primary productive
portion and a secondary non-productive portion, the
device comprising:
an expandable frame formed of a plurality of ribs
having distal ends secured to a central hub and
free, outwardly flared, proximal ends,
a pressure receiving membrane formed at least in part
of flexible material, the membrane forming a
recess in an expanded, deployed configuration,
wherein the membrane comprises a loose and
flexible peripheral region configured to seal to a
ventricular wall surface to partition the ventricle
and create the secondary non-productive portion,
wherein the flexible peripheral region of the
membrane comprises notched serrations; and
an outwardly biased member which is secured to the
membrane at a position that is radially inward from
the loose peripheral region of the membrane,
wherein the outwardly biased member is
configured to stiffen at least a portion of the
membrane so as to reduce wrinkling of the
membrane so that the peripheral region of the
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membrane may seal against a ventricular wall
surface defining in part the heart chamber.
C. Claim Construction
Consistent with the statute and the legislative history of the AIA, the Board
will interpret claims of an unexpired patent using the broadest reasonable
construction in light of the specification of the patent. See Office Patent Trial
Practice Guide, 77 Fed. Reg. 48756, 48766 (Aug. 14, 2012); 37 CFR
§ 42.100(b). Petitioner does not propose any constructions deviating from this
standard. Pet. 5. Patent Owner directs no comments to claim construction in the
Preliminary Response.
II. ANALYSIS
A. Overview
Petitioner contends that claims 1 and 10 are (1) obvious over Murphy and
Khairkhahan in combination with either Lane or Salahieh, and (2) obvious over
Lesh, Khairkhahan, and Nikolic, also in combination with either Lane or Salahieh.
Pet. 3; see chart supra.
B. Obviousness of claims 1 and 10 over Murphy, Khairkhahan, and Lane
Petitioner’s presentation of this challenge appears at pages 5-17 of the
petition.
Murphy describes a device and method for reshaping a ventricle that has
non-viable tissue in its wall. Col. 6, l. 65–col. 7, l. 7. The ventricle is reshaped by
“imbricating” it, meaning that edges of the ventricle wall having non-viable tissue
between them are brought together so that the non-viable tissue is excluded. Id.
Figure 2b of Murphy is reproduced below:
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Figure 2b shows a shaping device 210, which has a main wire 212 running
through its center and a series of back ribs 214a-d coupled to the main wire at
collar 216. Col. 4, ll. 45-50. A patch (not shown) may be coupled to the shaping
device. Col. 6, ll. 31-33. The patch is sized to cover the non-viable tissue that is to
be excluded, col. 8, ll. 6-11, and is positioned to align with that tissue. Col. 10,
ll. 44-47. The ventricle wall is reshaped by pressing it against the shaping device
using a molding instrument. Col. 7, ll. 8-13. A clasping instrument applies
implements (such as sutures, staples, or clips) to the ventricle wall along the edges
of the portion to be excluded. Id. at ll. 13-21. When the implements are closed,
the ventricle wall will have been pulled over the shaping device and will maintain
its shape. Id. at ll. 25-28.
Khairkhahan describes devices and methods for occluding the left atrial
appendage, a portion of the heart in which blood may clot when it stagnates there
during atrial fibrillation. Khairkhahan ¶ [0003].
Figures 3 and 4 of Khairkhahan are reproduced below:
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Figures 3 and 4 show an occluding device 10, which has an occlusion
member 11 and stabilizing member 194. Id. at ¶ [0062]. The occlusion member
includes a mesh-like barrier 15 secured to a frame that is formed by an array of
radially outwardly-extending spokes 17. Id. at ¶¶ [0044], [0047], [0048]. The
spokes extend from hub 16. Id. at ¶ [0046]. Each spoke has a proximal zone 212
with an “enhanced degree of flexibility” to assist engagement of the occlusion
member with the wall of the left atrial appendage. Id. at ¶ [0064]. Each spoke
terminates with a proximal point 214, which may be either embedded in the barrier
or extend beyond it to assist further with engagement. Id. at ¶ [0065].
Lane describes replacement heart valve assemblies. Abstr. The assembly
includes a prosthesis, which serves as an interface between the surrounding tissue
and the replacement valve. Col. 1, ll. 60-67. The prosthesis includes an annular
ring that is implantable in the surrounding tissue and a sewing cuff to which the
replacement valve is stitched. Id.
Detail from Figure 17A is reproduced below:
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The detail from Figure 17A shows a heart valve assembly, which includes a
prosthesis (gasket member 312) and a valve (crown 314). Col. 24, ll. 19-21. The
gasket member includes annular ring 318, flexible baleen element 330, sewing cuff
320, and covering fabric 336. Id. at ll. 22-26. The baleen element has a base 380
from which fingers 382 extend. Col. 25, ll. 57-59. The fingers may be biased to
extend outwardly. Id. at 65-66. When they do so, they press the fabric covering
against the surrounding tissue to enhance the seal formed by the gasket member.
Col. 27, l. 64 to col. 28, l. 2. The fingers may have uniform or varying lengths,
may define undulations or lobes, or may vary in thickness. Col. 26, ll. 4-15;
Figs. 20A-D.
Petitioner argues that Murphy and Khairkhahan disclose all limitations of
each of claims 1 and 10 except the requirement that the peripheral region of the
membrane have “notched serrations.” Pet. 6-7. In particular, Petitioner contends
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that Khairkhahan discloses the claimed outwardly biased member. Pet. 9, 13.
Petitioner argues that Lane discloses the notched serrations. Id. at 7-8. Petitioner
asserts that a person having ordinary skill in the art would have had reason to
combine the relevant teachings of Murphy, Khairkhahan, and Lane to reach the
claimed subject matter because these references “are related to the repair of a
human heart.” Pet. 5; see also Pet. 9.
Patent Owner argues, among other things, that the petition fails to explain
how Khairkhahan discloses the outwardly biased member. Prelim. Resp. 10,
37-39. Patent Owner also argues that Petitioner has made no more than a bare
assertion of obviousness, without any explanation of how the teachings of the
references would be arranged or combined or why a person of ordinary skill would
have made the combination. Prelim. Resp. 8, 39-41.
We agree with Patent Owner on both points. The fact that Murphy,
Khairkhahan, and Lane all concern human heart repair is not in itself sufficient
rationale for making the combination. Many heart repair devices exist. That fact
alone would not make it obvious to combine their features. Petitioner must show
some reason why a person of ordinary skill in the art would have thought to
combine particular available elements of knowledge, as evidenced by the prior art,
to reach the claimed invention. See KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398,
418 (2007). This, the Petitioner has not done. That the references relied upon all
relate to human heart repair does not amount to “some articulated reasoning with
some rational underpinning to support the legal conclusion of obviousness.” See
id. (internal quotations omitted).
Moreover, we agree further with Patent Owner that Petitioner has not
explained satisfactorily how the references, when combined, meet the “outwardly
biased member” limitation. Petitioner relies on Khairkhahan alone for disclosure
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of this limitation, but simply reproduces Khairkhahan’s Figure 3 and paraphrases
two paragraphs of Khairkhahan’s specification. See, e.g., Pet. 13. Petitioner does
not identify what structure shown or described in these excerpts meets the
limitation. No structure shown in the Khairkhahan excerpts Petitioner relies on is
plainly an “outwardly biased member” as recited in claims 1 and 10. The petition
thus does not make clear the relevance of the cited disclosure to the claim
limitation at issue. It was Petitioner’s burden to demonstrate how the prior art
would have made obvious the claimed subject matter as a whole, and Petitioner has
not done this. Petitioner’s presentation is incomplete in this respect and, therefore,
insufficient to demonstrate a reasonable likelihood of prevailing on this
obviousness challenge.
For these reasons, we determine that Petitioner has not demonstrated a
reasonable likelihood that claims 1 and 10 are unpatentable over Murphy,
Khairkhahan, and Lane.
C. Obviousness of claims 1 and 10 over Murphy, Khairkhahan, and
Salahieh
Petitioner’s presentation of this challenge appears at pages 17-28 of the
petition. This challenge, however, suffers from the same deficiencies discussed
above. Petitioner offers the same inadequate rationale for combining the
respective references: that they all relate to repair of the human heart. See Pet. 18.
As discussed, this assertion is insufficient to support an obviousness challenge.
See supra. Moreover, this challenge also relies on Khairkhahan for disclosing the
“outwardly biased member” limitation, but Petitioner does not explain how the
cited passages of Khairkhahan meet that limitation. See, e.g., Pet. 25.
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For these reasons, we determine that Petitioner has not demonstrated a
reasonable likelihood of prevailing on its assertion that claims 1 and 10 are
unpatentable over Murphy, Khairkhahan, and Salahieh.
D. Obviousness of claims 1 and 10 over Lesh, Khairkhahan, Nikolic, and
Lane
Petitioner’s presentation of this challenge appears at pages 28-45 of the
petition.
Lesh, like Khairkhahan, describes devices and methods for occluding the left
atrial appendage. Abstr. Figure 1 is reproduced below:

Figure 1 of Lesh shows an occluding device 10 having occluding member 11
and retention member 12. Col. 7, ll. 31-33. The occluding member is disc-shaped
and is formed from a frame structure 14 of arms extending from hub 16 to outer
rim 13. Id. at ll. 35-41. The outer rim may contain a radial hoop 21 that maintains
the ring shape of the outer rim and facilitates its radial expansion. Id. at ll. 64-67.
The outer rim seals against the surface of the left atrial appendage. Col. 8,
ll. 60-62.
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This challenge suffers from the same deficiencies as the challenges
discussed above. Petitioner offers the same inadequate rationale for combining the
respective references: that they all relate to repair of the human heart. See Pet. 29.
As discussed, this assertion is insufficient to support an obviousness challenge.
See supra.
Petitioner also does not persuade us that the cited references disclose the
“outwardly biased member” limitation. Petitioner cites Khairkhahan and Lesh as
each disclosing this limitation. See, e.g., Pet. 38-39. Petitioner excerpts from
Khairkhahan the same portions as in the challenges discussed supra, and similarly
gives no explanation as to how the cited passages meet the claim limitation.
Petitioner also cites Figures 1-3 of Lesh and portions of the specification that
describe the outer rim and the radial hoop. Id. Petitioner, however, does not
explain how either of these structures satisfies the requirement that the outwardly
biased member be “at a position that is radially inward” from the peripheral region
of the membrane. As can be seen in Lesh’s Figure 1, and as can be inferred from
its name, the outer rim is at the outermost edge of the occluding device. Petitioner
has not explained how Lesh’s radially outermost position meets the claimed
“position that is radially inward.”
Thus, Petitioner has neither provided an adequate rationale for the
combination of the cited references, nor shown that the references, when
combined, disclose the claimed subject matter or otherwise would have made it
obvious. For these reasons, we determine that Petitioner has not demonstrated a
reasonable likelihood that claims 1 and 10 are unpatentable over Lesh,
Khairkhahan, Nikolic, and Lane.
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E. Obviousness of claims 1 and 10 over Lesh, Khairkhahan, Nikolic, and
Salahieh
Petitioner’s presentation of this challenge appears at pages 45-59 of the
petition. This challenge suffers from the same deficiencies discussed in section
II.D, supra, for the challenge based on Lesh, Khairkhahan, Nikolic, and Lane.
Petitioner offers the same inadequate rationale for combining the respective
references as for the other challenges: that they all relate to repair of the human
heart. See Pet. 45. This assertion is insufficient to support an obviousness
challenge. Moreover, this challenge relies on Khairkhahan or Lesh for disclosing
the “outwardly biased member” limitation, but Petitioner does not explain how the
cited passages of Khairkhahan or Lesh meet that limitation. See, e.g., Pet. 54-55.
For these reasons, we determine that Petitioner has not demonstrated a
reasonable likelihood that claims 1 and 10 are unpatentable over Lesh,
Khairkhahan, Nikolic, and Salahieh.
III. SUMMARY
Petitioner has not shown that there is a reasonable likelihood that it would
prevail with respect to at least one of the claims challenged in the petition. The
petition is therefore denied.
IV. ORDER
For the reasons given, it is
ORDERED that the petition challenging the patentability of claims 1
and 10 of Patent 7,582,051 is denied.

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For PETITIONER:

Sanford E. Warren, Jr.
R. Scott Rhodes
AKIN GUMP STRAUSS HAUER & FELD LLP
swarren@akingump.com
srhoades@akingump.com

For PATENT OWNER:

Richard Shoop
James Shay
SHAY GLENN LLP
rick@shayglenn.com
jim@shayglenn.com